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Optimize RV Selective Site Pacing Clinical Trial | Clinical Trials | Clareo Health

TERMINATEDNA

Optimize RV Selective Site Pacing Clinical Trial

NCT00422669•Medtronic Cardiac Rhythm and Heart Failure

Summary

The purpose of the Optimize RV study is to determine the long-term effect of selective site pacing. Selective site pacing refers to which area of the right ventricle the lead is placed. The goal of select site pacing is to improve how the heart contracts when paced in the ventricle. By pacing in select sites, it is possible to better copy the natural pattern of contraction of the heart.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects that are expected to be paced in the right ventricle (RV) greater than 90 percent of the time
•Subjects with an ejection fraction of greater than 40 percent within 3 months prior to enrollment
•Subjects greater than 18 yrs of age
•Subjects that are indicated for a dual chamber pacemaker
•Subjects that will be implanted with a market released dual chamber Medtronic pacemaker and 3830 SelectSecure Lead in the ventricle

Exclusion Criteria

•Subjects indicated for cardiac resynchronization therapy (CRT) device (based on American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines)
•Subjects indicated for an implantable cardiac defibrillator (ICD)
•Subjects with permanent atrial fibrillation (AF)
•Subjects with expected managed ventricular pacing turned on
•Subjects with a previously implanted pacemaker, ICD, or CRT device
•Subjects with an myocardial infarction (MI) within 3 months prior to enrollment
•Subjects that received bypass surgery within 3 months prior to enrollment
•Subjects that had valve replacement within 3 months prior to enrollment
•Subjects where a RV lead cannot be placed, (i.e., complex congenital heart disease
•Subjects with a mechanical right heart valve
+4 more criteria

Locations (22)

Bridgeport, Connecticut, United States

Clearwater, Florida, United States

Hudson, Florida, United States

Des Moines, Iowa, United States

Silver Spring, Maryland, United States

Takoma Park, Maryland, United States

Southfield, Michigan, United States

Saint Paul, Minnesota, United States

Omaha, Nebraska, United States

Cleveland, Ohio, United States

Key Dates

Start Date

January 1, 2007

Primary Completion Date

May 1, 2009

Completion Date

May 1, 2009

Last Updated

January 31, 2013

Enrollment

205

ACTUAL participants

Conditions

Cardiac Pacing, ArtificialCardiac Pacemaker, Artificial

Interventions

Medtronic Dual-Chamber Pacemaker

DEVICE

Medtronic SelectSecure 3830 Lead

DEVICE

BIO|MASTER.CSP Study

NCT06620237

Cardiac Pacing, ArtificialCardiac Pacemaker, Artificial+5 more

View study

COMPLETEDNA

Clinical Investigation Plan for the AVOPT Data Collection Clinical Study

NCT03049722

Cardiac Pacemaker, Artificial

View study

TERMINATED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 31, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Optimize RV Selective Site Pacing Clinical Trial

Inclusion Criteria

Exclusion Criteria

BIO|MASTER.CSP Study

Clinical Investigation Plan for the AVOPT Data Collection Clinical Study

Dual Chamber Versus Single Chamber Cardiac Pacing in People 80 Years of Age and Older